Class II · Moderate risk
Ondansetron Hydrochloride
Lack of assurance of sterility.
Heartburn & Stomach Medication Recalls
Recalls of acid reducers and stomach drugs - the class behind the ranitidine (Zantac) nitrosamine recalls.
211 recalls in this category, newest first.
Class II · Moderate risk
Pantoprazole Sodium for Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ondansetron HCL
cGMP deviations: Temperature abuse
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP deviations: tablets cracking
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Moderate risk
Omeprazole Delayed Release Capsules
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Prilosec (Omeprazole Magnesium)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ondansetron HCL 4mg 30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Class III · Low risk
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion…
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Famotidine Tablets USP 40mg
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class III · Low risk
Famotidine Injection
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Class III · Low risk
Esomeprazole Magnesium Delayed Release Capsules USP
Discoloration: product contains brown pellets
Class II · Moderate risk
Nizatidine Oral Solution
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Class II · Moderate risk
Ranitidine 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Hydrochloride
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
ranitidine hydrochloride
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
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